# K230036: Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand )

- Pathway: 510(k) (Traditional)
- Applicant: Rti Surgical, Inc.
- Decided: Jun 23, 2023 after 178 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K990088 (1999). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181633: MTF Pre-Sutured Tendon, Musculoskeletal Transplant Foundation (2019) Summary page 4.
- K170957: ReConnex Pre-Sutured Tendon, Allosource (2018) Summary page 4.

## Most influential descendants
- K253145: Pre-Sutured Tendon (2025), 0 descendants of its own

## Indications for use
The Pre-Sutured Tendon is intended for use as a construct in anterior cruciate ligament and posterior cruciate ligament reconstruction. The Pre-Sutured Tendon is for single patient use only.

Source page: https://510kreport.com/device/K230036
Methodology: https://510kreport.com/methodology